KR20190104043A - TNFα에 대한 재조합 단일클론 항체의 약학적 수성 조성물 - Google Patents
TNFα에 대한 재조합 단일클론 항체의 약학적 수성 조성물 Download PDFInfo
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- adalimumab
- polysorbate
- aqueous composition
- trehalose
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Applications Claiming Priority (5)
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RU2016152691 | 2016-12-30 | ||
RU2016152691A RU2665966C2 (ru) | 2016-12-30 | 2016-12-30 | Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОα |
RU2017146821A RU2764521C2 (ru) | 2017-12-29 | 2017-12-29 | Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОа |
PCT/RU2017/050133 WO2018124948A1 (ru) | 2016-12-30 | 2017-12-29 | ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα |
RU2017146821 | 2017-12-29 |
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KR20190104043A true KR20190104043A (ko) | 2019-09-05 |
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KR1020197022011A KR20190104043A (ko) | 2016-12-30 | 2017-12-29 | TNFα에 대한 재조합 단일클론 항체의 약학적 수성 조성물 |
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EP (1) | EP3563867A4 (es) |
JP (1) | JP2020506955A (es) |
KR (1) | KR20190104043A (es) |
AU (1) | AU2017384942A1 (es) |
BR (1) | BR112019013673A2 (es) |
CL (1) | CL2019001818A1 (es) |
CR (1) | CR20190316A (es) |
EC (1) | ECSP19048656A (es) |
JO (1) | JOP20190162A1 (es) |
MX (1) | MX2019007911A (es) |
NI (1) | NI201900072A (es) |
PE (1) | PE20191550A1 (es) |
PH (1) | PH12019501530A1 (es) |
WO (1) | WO2018124948A1 (es) |
ZA (1) | ZA201904305B (es) |
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WO2021182874A1 (ko) * | 2020-03-13 | 2021-09-16 | 삼성바이오에피스 주식회사 | 안정성이 증진된 액상 약제학적 조성물 |
RU2745814C1 (ru) * | 2020-06-05 | 2021-04-01 | Закрытое Акционерное Общество "Биокад" | Водная фармацевтическая композиция левилимаба и ее применение |
BR112023019201A2 (pt) * | 2021-03-24 | 2023-10-17 | Japan Chem Res | Composição farmacêutica aquosa ou composição farmacêutica liofilizada |
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---|---|---|---|---|
US521206A (en) | 1894-06-12 | Frank b | ||
EP0230574A3 (en) | 1986-01-31 | 1989-03-22 | Yale University | Pharmaceutical compositions against infections caused by lav/htlv iii virus and the use thereof |
DE3631229A1 (de) | 1986-09-13 | 1988-03-24 | Basf Ag | Monoklonale antikoerper gegen humanen tumornekrosefaktor (tnf) und deren verwendung |
DE68927671T2 (de) | 1988-12-19 | 1997-05-07 | American Cyanamid Co | Produkte zur Behandlung des Endotoxin -Schocks bei einem Säugetier |
US5959087A (en) | 1989-08-07 | 1999-09-28 | Peptide Technology, Ltd. | Tumour necrosis factor binding ligands |
US6498237B2 (en) | 1989-08-07 | 2002-12-24 | Peptech Limited | Tumor necrosis factor antibodies |
AU630497B2 (en) | 1989-09-05 | 1992-10-29 | Immunex Corporation | Tumor necrosis factor-alpha and -beta receptors |
GB8921123D0 (en) | 1989-09-19 | 1989-11-08 | Millar Ann B | Treatment of ards |
DE4037604A1 (de) | 1990-04-25 | 1991-10-31 | Bayer Ag | Verwendung von anti-tnf-antikoerpern als arzneimittel bei der behandlung von ischaemien und deren folgen |
CA2288429C (en) | 1991-03-15 | 2006-04-25 | Synergen, Inc. | Pegylation of polypeptides |
US5656272A (en) | 1991-03-18 | 1997-08-12 | New York University Medical Center | Methods of treating TNF-α-mediated Crohn's disease using chimeric anti-TNF antibodies |
DK0604418T3 (da) | 1991-03-29 | 1999-06-14 | Immunex Corp | Isolerede viralproteincytokinantagonister |
WO1993011793A1 (en) | 1991-12-17 | 1993-06-24 | Schering Corporation | Use of the combination of anti-tumor necrosis factor plus interleukin-6 to treat septic shock |
WO1993019751A1 (en) | 1992-04-02 | 1993-10-14 | Smithkline Beecham Corporation | Compounds useful for treating inflammatory diseases and inhibiting production of tumor necrosis factor |
ATE172880T1 (de) | 1992-08-28 | 1998-11-15 | Bayer Ag | Verwendung von monoklonalen anti-tnf-antikörpern für die behandlung von bakteriellen meningitiden |
AU670125B2 (en) | 1992-09-15 | 1996-07-04 | Immunex Corporation | Method of treating tnf-dependent inflammation using tumor necrosis factor antagonists |
WO1994008609A1 (en) | 1992-10-15 | 1994-04-28 | Dana-Farber Cancer Institute, Inc. | TREATMENT OF INSULIN RESISTANCE IN OBESITY LINKED TYPE II DIABETES USING ANTAGONISTS TO TNF-α FUNCTION |
DE4307508A1 (de) | 1993-03-10 | 1994-09-15 | Knoll Ag | Verwendung von anti-TNF-Antikörpern als Arzneimittel bei der Behandlung von Herzinsuffizienz (Herzmuskelschwäche) |
NZ278607A (en) | 1994-02-07 | 1999-05-28 | Knoll Ag | Use of tnf antagonists for treating disorders involving elevated serum levels of il-6 wherein the serum levels are 500pg/ml or above |
US6090382A (en) | 1996-02-09 | 2000-07-18 | Basf Aktiengesellschaft | Human antibodies that bind human TNFα |
CN101712720A (zh) | 1996-02-09 | 2010-05-26 | 艾博特生物技术有限公司 | 结合人TNFα的人抗体 |
UA81743C2 (uk) | 2000-08-07 | 2008-02-11 | Центокор, Инк. | МОНОКЛОНАЛЬНЕ АНТИТІЛО ЛЮДИНИ, ЩО СПЕЦИФІЧНО ЗВ'ЯЗУЄТЬСЯ З ФАКТОРОМ НЕКРОЗУ ПУХЛИН АЛЬФА (ФНПα), ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО ЙОГО МІСТИТЬ, ТА СПОСІБ ЛІКУВАННЯ РЕВМАТОЇДНОГО АРТРИТУ |
US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
KR20110138412A (ko) * | 2009-04-16 | 2011-12-27 | 애보트 바이오테라퓨틱스 코포레이션 | 항-ΤΝF-α 항체 및 그의 용도 |
MX344727B (es) | 2010-11-11 | 2017-01-05 | Abbvie Biotechnology Ltd | Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas. |
MX363700B (es) * | 2012-03-07 | 2019-03-29 | Cadila Healthcare Ltd | Formulaciones farmaceuticas de anticuerpos tnf-alfa. |
WO2016120413A1 (en) * | 2015-01-28 | 2016-08-04 | Mabxience S.A. | Pharmaceutical formulations for anti-tnf-alpha antibodies |
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2017
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- 2017-12-29 EP EP17885720.7A patent/EP3563867A4/en not_active Withdrawn
- 2017-12-29 JP JP2019556787A patent/JP2020506955A/ja active Pending
- 2017-12-29 WO PCT/RU2017/050133 patent/WO2018124948A1/ru active Search and Examination
- 2017-12-29 PE PE2019001351A patent/PE20191550A1/es unknown
- 2017-12-29 BR BR112019013673A patent/BR112019013673A2/pt not_active IP Right Cessation
- 2017-12-29 MX MX2019007911A patent/MX2019007911A/es unknown
- 2017-12-29 CR CR20190316A patent/CR20190316A/es unknown
- 2017-12-29 AU AU2017384942A patent/AU2017384942A1/en active Pending
- 2017-12-29 KR KR1020197022011A patent/KR20190104043A/ko not_active Application Discontinuation
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2019
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- 2019-06-28 ZA ZA2019/04305A patent/ZA201904305B/en unknown
- 2019-07-09 EC ECSENADI201948656A patent/ECSP19048656A/es unknown
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CR20190316A (es) | 2019-09-04 |
EP3563867A1 (en) | 2019-11-06 |
PE20191550A1 (es) | 2019-10-24 |
NI201900072A (es) | 2019-10-31 |
JP2020506955A (ja) | 2020-03-05 |
JOP20190162A1 (ar) | 2019-06-27 |
BR112019013673A2 (pt) | 2020-01-28 |
CL2019001818A1 (es) | 2019-11-29 |
EP3563867A4 (en) | 2020-12-16 |
WO2018124948A8 (ru) | 2018-09-27 |
PH12019501530A1 (en) | 2020-02-24 |
ECSP19048656A (es) | 2019-07-31 |
MX2019007911A (es) | 2019-12-05 |
WO2018124948A1 (ru) | 2018-07-05 |
AU2017384942A1 (en) | 2019-08-08 |
ZA201904305B (en) | 2022-04-28 |
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